Pharmaceutical composition of vinflunine which is intended for parenteral administration preparation method thereof and use of same

Abstract

The invention relates to a pharmaceutical composition of vinflunine in the form of a stable sterile aqueous solution of a water-soluble salt of vinflunine with a pH of between 3 and 4. The invention also relates to the method of preparing said composition and to the use thereof as a parenterally-administered medicament for the treatment of cancer.

1 . Method for treating cancer comprising the parenteral administration of an effective amount to a patient in need thereof of a composition of vinflunine, wherein said composition is in the form of a sterile injectable aqueous solution of vinflunine ditartrate without the addition of a buffer system. 
     
     
         2 . Method according to  claim 1  wherein the composition contains vinflunine ditartrate with a base vinflunine concentration of between 25 and 30 mg/ml. 
     
     
         3 . Method according to  claim 2  wherein the concentration of vinflunine base is of 25 mg/ml. 
     
     
         4 . Method according to  claim 1  wherein the pH of said composition is between 3.0 and 4.0. 
     
     
         5 . Method according to  claim 3  wherein the pH of said composition is 3.5. 
     
     
         6 . Method according to  claim 1  wherein the composition has been prepared up to 36 months before its administration. 
     
     
         7 . Method according to  claim 1  or  6  wherein the composition has been stored at 5° C.±3° C. 
     
     
         8 . Method according to  claim 1  wherein the parenteral administration is via intravenous infusion. 
     
     
         9 . Method according to  claim 1  wherein the composition corresponds to one of the following formulations:
 68.35 mg of vinflunine ditartrate qs to 2 ml in water, or 
 136.70 mg of vinflunine ditartrate qs to 4 ml of water or 
 341.75 mg of vinflunine ditartrate qs to 10 ml of water 
 
     
     
         10 . Method according to  claim 1  wherein the composition has been prepared in the following way:
 (a) dissolution of vinflunine ditartrate in water for injectable preparations, 
 (b) sterilization by filtration of the bulk solution, 
 (c) aseptic distribution, under a nitrogen atmosphere, of the sterile composition obtained in step (c) in the container, advantageously chosen from glass phials, glass bottles and prefilled syringes. 
 
     
     
         11 . Method according to  claim 1  wherein the composition is contained in a packaging container.